A Long-term Extension Study of Ustekinumab in Pediatric Participants (UNITED)

A Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study of Ustekinumab in Pediatric Clinical Study Participants (2 to <18 Years of Age)

The purpose of this study is to collect long-term safety data of subcutaneous (SC) ustekinumab

Study Overview

• Status: Active, not recruiting
• Conditions: Crohn Disease; Arthritis, Psoriatic; Colitis, Ulcerative
• Intervention / Treatment: Drug: Ustekinumab

• Study Type: Interventional
• Enrollment (Actual): 159
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1060
    • STAT Research S A
  • Córdoba, Argentina, X5014FTO
    • Hospital de Ninos de Cordoba
  • San Miguel de Tucumán, Argentina, T4000AXL
    • Centro de Investigaciones Medicas Tucuman
• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint Luc
  • Brussels, Belgium, 1020
    • Huderf
  • Ghent, Belgium, 9000
    • UZ Gent
  • Jette, Belgium, 1090
    • UZ Brussel
  • Leuven, Belgium, 3000
    • UZ Gasthuisberg
• France
  • Paris, France, 75015
    • Hôpital Necker
• Germany
  • Aachen, Germany, 52074
    • Universitaetsklinikum der RWTH Aachen
  • Berlin, Germany, 13353
    • Charite Universitatsmedizin Berlin Campus Virchow Klinikum
• Hungary
  • Budapest, Hungary, 1083
    • Semmelweis Egyetem
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
  • Miskolc, Hungary, 3526
    • Borsod Abauj Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz
  • Nyíregyháza, Hungary, 4400
    • Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz
  • Szeged, Hungary, 6720
    • Szegedi Tudomanyegyetem
• Israel
  • Beer Yaakov, Israel, 70300
    • Yitzhak Shamir Medical Center
  • Jerusalem, Israel, 9103102
    • Shaare Zedek Medical Center
  • Ramat Gan, Israel, 5266202
    • Sheba Medical Center
• Italy
  • Milan, Italy, 20122
    • Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
• Japan
  • Bunkyō City, Japan, 113 8431
    • Juntendo University Hospital
  • Gunma, Japan, 371-0034
    • Gunma University Hospital
  • Ikoma, Japan, 630 0293
    • Kindai University Nara Hospital
  • Kurume, Japan, 830-0011
    • Kurume University Hospital
  • Saitama Shi, Japan, 330-8777
    • Saitama Childrens Medical Center
  • Sendai, Japan, 989-3126
    • Miyagi Childrens Hospital
  • Setagaya Ku, Japan, 157 8535
    • National Center for Child Health and Development
  • Tsu, Japan, 514 8507
    • Mie University Hospital
• Poland
  • Krakow, Poland, 30 663
    • Uniwersytecki Szpital Dzieciecy w Krakowie
  • Rzeszów, Poland, 35-302
    • Korczowski Bartosz Gabinet Lekarski
  • Sosnowiec, Poland, 41 200
    • Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu Sp z o o
  • Torun, Poland, 87 100
    • GASTROMED Sp. z o.o.
  • Warsaw, Poland, 04 730
    • Instytut Pomnik Centrum Zdrowia Dziecka
  • Warsaw, Poland, 04-501
    • Medical Network
  • Warsaw, Poland, 04-501
    • Medical Network 1
• Spain
  • Valencia, Spain, 46026
    • Hosp. Univ. I Politecni La Fe
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06230
    • Hacettepe University Medical Faculty
  • Istanbul, Turkey (Türkiye), 34098
    • Cerrahpasa Medical Faculty Hospital
• United Kingdom
  • Birmingham, United Kingdom, B4 6NH
    • Birmingham Children's Hospital
  • Cambridge, United Kingdom, Cb2 2qq
    • Addenbrookes Hospital
  • London, United Kingdom, E1 1BB
    • Royal London Hospital
  • London, United Kingdom, WC1N 3JH
    • Great Ormond Street Hospital
  • Sheffield, United Kingdom, S10 2TH
    • Sheffield Children's Hospital
  • Southampton, United Kingdom, SO16 6YD
    • Southampton University Hospital
• United States
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Children's Center For Digestive Healthcare, Llc
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Levine Childrens at Atrium Health
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Pediatric Specialists Of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Must have completed the dosing planned in the primary pediatric ustekinumab study
• Benefit of continued ustekinumab therapy (that is, a clinical response or clinical remission as defined in the primary study at the final efficacy visit of the primary study)
• Parent(s) (preferably both if available or as per local requirements), legal guardian(s) or their legally acceptable representative must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to allow the child to participate in the study. Assent is also required of children capable of understanding the nature of the study (typically 7 years of age and older) as described in Informed Consent Process. An adolescent who signs the assent form will be given the opportunity to sign an adult ICF at a later visit when they reach the age of majority during the study to indicate that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
• Must be willing and able to adhere to the lifestyle restrictions specified in this protocol
• Females of childbearing potential must have a negative urine pregnancy test at enrollment and prior to study intervention administration

Exclusion Criteria:

• Are pregnant, nursing, or planning pregnancy or fathering a child
• Have had any of (a) confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2 [COVID-19]) infection (test positive), or (b) suspected SARS-CoV-2 infection (clinical features without documented test results), or (c) close contact with a person with known or suspected SARS-CoV-2 infection: Exception: (i) may be included with a documented negative result for a validated SARS-CoV-2 test: obtained at least 2 weeks after conditions (a), (b), (c) above (timed from resolution of key clinical features if present, example, fever, cough, dyspnea) and (ii) with absence of all conditions (a), (b), (c) above during the period between the negative test result and the baseline study visit
• Taken any disallowed therapies as noted in the primary study, before the planned first long-term extension (LTE) dose of study intervention
• Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
• Participants who receive a live vaccination may be permitted to remain in the study, if approved by the sponsor and study intervention is held for a period of time specified by the sponsor. Receipt of a live severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) vaccine (against the virus that causes Coronavirus Disease 2019 [COVID-19]) is not automatically an exclusion criterion and must be discussed with the medical monitor

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Ustekinumab; Participants will have continued access to ustekinumab for primary study (CNTO1275CRD1001, CNTO1275PUC3001, CNTO1275CRD3004, CNTO1275JPA3001) participants who in the opinion of the investigator will continue to benefit from ustekinumab therapy. All blinded participants who enroll in the long-term extension (LTE) from blinded primary studies with both every 8 weeks (q8w) and every 12 weeks (q12w) dosing groups just prior to the end of the primary study will be assigned to the q8w dosing regimen. Participants enrolling in the LTE from an unblinded primary study will remain on the final dosing regimen that they were receiving in the primary study. Participants enrolling from the Exposure Optimization Substudy may be eligible to remain on the every 4 weeks (q4w) dosing regimen.

Drug: Ustekinumab; Ustekinumab will be administered as a SC injection.; Other Names: STELARA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events (AEs)	An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study.	Up to 6 years and 4 months
Number of Participants With Serious Adverse Events (SAEs)	A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.	Up to 6 years and 4 months
Number of Participants with AEs Leading to Discontinuation of Study Intervention	Number of participants with AEs leading to discontinuation of study intervention will be reported.	Up to 6 years and 4 months
Number of Participants with AEs of Interest	Number of participants with AEs of special interest (any newly identified malignancy case of active tuberculosis [TB], or opportunistic infection occurring after the first administration of study intervention[s]) will be reported.	Up to 6 years and 4 months
Number of Participants with Abnormalities in Clinical Laboratory Parameters	Number of participants with abnormalities in clinical laboratory parameters (such as hematology and serum chemistry) will be reported.	Up to 6 years and 4 months
Number of Participants with Injection-site Reactions	Number of participants with injection-site reactions will be reported. An injection-site reaction is any adverse reaction at a subcutaneous (SC) study intervention injection-site.	Up to 6 years and 4 months
Number of Participants With AEs of Worsening of the Disease	Number of participants with AEs of worsening of the disease will be reported.	Up to 6 years and 4 months
Number of Participants With Concomitant Therapy due to Loss of Response	Number of participants with concomitant therapy due to loss of response will be reported.	Up to 6 years and 4 months

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2021
• Primary Completion (Estimated): September 29, 2027
• Study Completion (Estimated): March 15, 2028

Study Registration Dates

• First Submitted: October 13, 2021
• First Submitted That Met QC Criteria: October 13, 2021
• First Posted (Actual): October 25, 2021

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Spinal Diseases; Spondylarthropathies; Skin Diseases, Papulosquamous; Skin Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Spondylarthritis; Spondylitis; Psoriasis; Colitis; Skin and Connective Tissue Diseases; Colitis, Ulcerative; Crohn Disease; Arthritis, Psoriatic; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Ustekinumab
• Other Study ID Numbers: CR109074; 2020-004457-76 (EudraCT Number); CNTO1275ISD3001 (Other Identifier: Janssen Research & Development, LLC); 2022-501067-40-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No